Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein

Abstract

A system for extracting a bodily fluid sample (e.g., an interstitial fluid [ISF] sample) and monitoring an analyte therein includes a disposable cartridge and a local controller module. The disposable cartridge includes a sampling module adapted to extract a bodily fluid sample and an analysis module adapted to measure an analyte (e.g., glucose) in the bodily fluid sample. The local controller module is in electronic communication with the disposable cartridge and is adapted to receive and store measurement data from the analysis module. An ISF extraction device includes a penetration member configured for penetrating and residing in a target site of a user's skin layer and, subsequently, extracting an ISF sample therefrom. The device also includes a pressure ring(s) adapted for applying pressure to the user's skin layer in the vicinity of the target site. The device is configured such that the pressure ring(s) is capable of applying pressure in an oscillating manner whereby an ISF glucose lag of the ISF sample extracted by the penetration member is mitigated. A method for extracting ISF includes providing an ISF fluid extraction device with a penetration member and a pressure ring(s). Next, a user's skin layer is contacted by the pressure ring(s) and penetrated by the penetration member. An ISF sample is then extracted from the user's skin layer while pressure is being applied in an oscillating manner by the pressure ring(s). The oscillating pressure mitigates an ISF glucose lag of the extracted ISF sample.

What is claimed is:  
     
         1 . A system for extracting an Interstitial Fluid (ISF) sample and monitoring an analyte therein, the system comprising: 
 a cartridge including: 
 a sampling module for extracting an ISF sample from a target site of a body; and  
 an analysis module for measuring an analyte in the ISF sample; and  
   a local controller module in electronic communication with the cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module includes at least one pressure ring adapted for applying pressure to the body in the vicinity of the target site, and    wherein the sampling module is configured such that the pressure ring is capable of applying the pressure in an oscillating manner whereby an ISF glucose lag of the ISF sample extracted by the sampling module is mitigated.    
     
     
         2 . The system of  claim 1 , wherein the pressure ring is configured to apply pressure for approximately 85 seconds of an approximately 15 minute sampling cycle.  
     
     
         3 . The system of  claim 1 , wherein the sampling module further includes a depth penetration control element.  
     
     
         4 . The system of  claim 3 , wherein the depth penetration control element is integrated with at least one pressure ring of the sampling module.  
     
     
         5 . The system of  claim 1 , wherein the sampling module includes a penetration member and the penetration member is moveable independently of the at least one pressure ring.  
     
     
         6 . The system of  claim 1 , wherein the sampling module includes a penetration member and the penetration member is fixed with respect to at least one pressure ring of the sampling module.  
     
     
         7 . The system of  claim 1 , wherein the sampling module employs a lag mitigating chemical to further mitigate the ISF glucose lag.  
     
     
         8 . The system of  claim 1 , wherein the lag mitigating chemical is a histamine chemical.  
     
     
         9 . The system of  claim 1 , wherein the sampling module employs ultrasound to further mitigate the ISF glucose lag.  
     
     
         10 . The system of  claim 1 , wherein the sampling module employs heat to further mitigate the ISF glucose lag.  
     
     
         11 . The system of  claim 1 , wherein the sampling module employs vacuum to further mitigate the ISF glucose lag.  
     
     
         12 . The system of  claim 1 , wherein the sampling module employs an electropotential to further mitigate the ISF glucose lag.  
     
     
         13 . The system of  claim 1 , wherein the sampling module employs non-oscillatory mechanical manipulation of the body to further mitigate the ISF glucose lag.  
     
     
         14 . A system for monitoring an analyte in Interstitial Fluid (ISF) of a user, the system comprising: 
 a cartridge including an analysis module for measuring an analyte in the ISF of the user; and    a local controller module in electronic communication with the cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the analysis module includes an analyte sensor configured to be at least partially implanted in a target site of the user, and    wherein the analysis module includes at least one pressure ring adapted for applying pressure to the body in the vicinity of the target site, and    wherein the analysis module is configured such that the pressure ring is capable of applying the pressure in an oscillating manner whereby an ISF glucose lag is mitigated.    
     
     
         15 . The system of  claim 14 , wherein the analysis module employs a lag mitigating chemical to further mitigate the ISF glucose lag.  
     
     
         16 . The system of  claim 14 , wherein the analysis module employs ultrasound to further mitigate the ISF glucose lag.  
     
     
         17 . The system of  claim 14 , wherein the analysis module employs heat to further mitigate the ISF glucose lag.  
     
     
         18 . The system of  claim 14 , wherein the analysis module employs vacuum to further mitigate the ISF glucose lag.  
     
     
         19 . The system of  claim 14 , wherein the analysis module employs an electropotential to further mitigate the ISF glucose lag.  
     
     
         20 . The system of  claim 14 , wherein the analysis module employs non-oscillatory mechanical manipulation of the body to further mitigate the ISF glucose lag.  
     
     
         21 . A system for extracting a bodily fluid sample and monitoring glucose therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring glucose in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein at least one of the analysis module and the local controller module employs a calibration algorithm that depends on a glucose concentration measured from capillary blood and measurement data from the analysis module.    
     
     
         22 . The system of  claim 21 , wherein the bodily fluid sample is an ISF sample and the measurement data from the analysis module is obtained with ISF glucose lag mitigation.  
     
     
         23 . The system of  claim 22 , wherein sampling module includes at least one pressure ring.  
     
     
         24 . The system of  claim 23 , wherein the sampling module is configured such that the pressure ring is capable of applying the pressure in an oscillating manner whereby an ISF glucose lag is mitigated.  
     
     
         25 . The system of  claim 21 , wherein the sampling module includes a penetration member, at least one pressure ring and the pressure ring is capable of applying the pressure in an oscillating manner whereby an ISF glucose lag is mitigated.  
     
     
         26 . A system for monitoring an analyte in a bodily fluid of a user, the system comprising: 
 a disposable cartridge including: 
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein at least one of the analysis module and the local controller module employs a calibration algorithm that depends on a glucose concentration measured from capillary blood and measurement data from the analysis module.    
     
     
         27 . The system of  claim 26 , wherein the bodily fluid sample is an ISF sample and the measurement data from the analysis module is obtained with ISF glucose lag mitigation.  
     
     
         28 . The system of  claim 27 , wherein sampling module includes at least one pressure ring.  
     
     
         29 . The system of  claim 28 , wherein the sampling module is configured such that the pressure ring is capable of applying the pressure in an oscillating manner whereby an ISF glucose lag is mitigated.  
     
     
         30 . The system of  claim 26 , wherein the sampling module includes a penetration member, at least one pressure ring and the pressure ring is capable of applying the pressure in an oscillating manner whereby an ISF glucose lag is mitigated.  
     
     
         31 . A system for extracting a bodily fluid sample and monitoring an analyte therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module employs a microdialysis-based sample extraction technique.    
     
     
         32 . The system of  claim 31 , wherein sampling module is configured to extract an interstitial fluid (ISF) sample and to measure glucose in the ISF sample and wherein the sampling module further includes means for mitigating ISF glucose lag.  
     
     
         33 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs a lag mitigating chemical.  
     
     
         34 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs ultrasound to mitigate ISF glucose lag.  
     
     
         35 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs heat to mitigate ISF glucose lag.  
     
     
         36 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs vacuum to mitigate ISF glucose lag.  
     
     
         37 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs an electropotential to mitigate ISF glucose lag.  
     
     
         38 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         39 . The system of  claim 32 , wherein the means for mitigating ISF glucose lag employs a combination of at least two of a lag mitigating chemical, ultrasound, heat, vacuum, an electropotential, and mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         40 . A system for extracting a bodily fluid sample and monitoring an analyte therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module employs an ultrafiltration-based sample extraction technique.    
     
     
         41 . The system of  claim 42 , wherein sampling module is configured to extract an interstitial fluid (ISF) sample and to measure glucose in the ISF sample and wherein the sampling module further includes means for mitigating ISF glucose lag.  
     
     
         42 . The system of  claim 41 , wherein the means for mitigating ISF glucose lag employs an ISF glucose lag mitigating chemical.  
     
     
         43 . The system of  claim 41 , wherein the means for mitigating ISF glucose lag employs ultrasound to mitigate ISF glucose lag.  
     
     
         44 . The system of  claim 41 , wherein the means for mitigating ISF glucose lag employs heat to mitigate ISF glucose lag.  
     
     
         45 . The system of  claim 41 , wherein the means for mitigating ISF glucose lag employs vacuum to mitigate ISF glucose lag.  
     
     
         46 . The system of  claim 41 , wherein the means for mitigating ISF glucose lag employs an electropotential to mitigate ISF glucose lag.  
     
     
         47 . The system of  claim 41 , wherein the means for mitigating ISF glucose lag employs mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         48 . The system of  claim 41 , wherein the means for mitigating glucose lag employs a combination of at least two of a lag mitigating chemical, ultrasound, heat, vacuum, an electropotential, and mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         49 . A system for extracting a bodily fluid sample and monitoring an analyte therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module employs a laser-based sample extraction technique.    
     
     
         50 . The system of  claim 49 , wherein sampling module is configured to extract an interstitial fluid (ISF) sample and to measure glucose in the ISF sample and wherein the sampling module further includes means for mitigating ISF glucose lag.  
     
     
         51 . The system of  claim 50 , wherein the means for mitigating ISF glucose lag employs a lag mitigating chemical.  
     
     
         52 . The system of  claim 50 , wherein the means for mitigating ISF glucose lag employs ultrasound to mitigate ISF glucose lag.  
     
     
         53 . The system of  claim 50 , wherein the means for mitigating glucose lag employs heat to mitigate ISF glucose lag.  
     
     
         54 . The system of  claim 50 , wherein the means for mitigating glucose lag employs vacuum to mitigate ISF glucose lag.  
     
     
         55 . The system of  claim 50 , wherein the means for mitigating glucose lag employs an electropotential to mitigate ISF glucose lag.  
     
     
         56 . The system of  claim 50 , wherein the means for mitigating glucose lag employs mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         57 . The system of  claim 50 , wherein the means for mitigating glucose lag employs a combination of at least two of a lag mitigating chemical, ultrasound, heat, vacuum, an electropotential and mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         58 . A system for extracting a bodily fluid sample and monitoring an analyte therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module employs a reverse iontophoresis-based sample extraction technique.    
     
     
         59 . The system of  claim 58 , wherein sampling module is configured to extract an interstitial fluid (ISF) sample and to measure glucose in the ISF sample and wherein the sampling module further includes means for mitigating ISF glucose lag.  
     
     
         60 . The system of  claim 59 , wherein the means for mitigating ISF glucose lag employs a lag mitigating chemical.  
     
     
         61 . The system of  claim 59 , wherein the means for mitigating glucose lag employs ultrasound to mitigate ISF glucose lag.  
     
     
         62 . The system of  claim 59 , wherein the means for mitigating glucose lag employs heat to mitigate ISF glucose lag.  
     
     
         63 . The system of  claim 59 , wherein the means for mitigating glucose lag employs vacuum to mitigate ISF glucose lag.  
     
     
         64 . The system of  claim 59 , wherein the means for mitigating glucose lag employs an electropotential to mitigate ISF glucose lag.  
     
     
         65 . The system of  claim 59 , wherein the means for mitigating glucose lag employs mechanical manipulation of the body to mitigate ISF glucose.  
     
     
         66 . The system of  claim 59 , wherein the means for mitigating glucose lag employs a combination of at least two of a lag mitigating chemical, ultrasound, heat, vacuum, an electropotential, and mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         67 . A system for extracting a bodily fluid sample and monitoring an analyte therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module employs an electroporation-based sample extraction technique.    
     
     
         68 . The system of  claim 67 , wherein sampling module is configured to extract an interstitial fluid (ISF) sample and to measure glucose in the ISF sample and wherein the sampling module further includes means for mitigating ISF glucose lag.  
     
     
         69 . The system of  claim 68 , wherein the means for mitigating ISF glucose lag employs a lag mitigating chemical.  
     
     
         70 . The system of  claim 68 , wherein the means for mitigating ISF glucose lag employs ultrasound to mitigate ISF glucose lag.  
     
     
         71 . The system of  claim 68 , wherein the means for mitigating ISF glucose lag employs heat to mitigate ISF glucose lag.  
     
     
         72 . The system of  claim 68 , wherein the means for mitigating glucose lag employs vacuum to mitigate lag.  
     
     
         73 . The system of  claim 68 , wherein the means for mitigating glucose lag employs an electropotential to mitigate lag.  
     
     
         74 . The system of  claim 68 , wherein the means for mitigating ISF glucose lag employs mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         75 . The system of  claim 68 , wherein the means for mitigating glucose lag employs a combination of at least two of a lag mitigating chemical, ultrasound, heat, vacuum, an electropotential, and mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         76 . A system for extracting a bodily fluid sample and monitoring an analyte therein, the system comprising: 
 a disposable cartridge including: 
 a sampling module for extracting a bodily fluid sample from a body; and  
 an analysis module for measuring an analyte in the bodily fluid sample; and  
   a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the sampling module employs an ultrasound-based sample extraction technique.    
     
     
         77 . The system of  claim 76 , wherein sampling module is configured to extract an interstitial fluid (ISF) sample and to measure glucose in the ISF sample and wherein the sampling module further includes means for mitigating ISF glucose lag.  
     
     
         78 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs a lag mitigating chemical.  
     
     
         79 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs ultrasound to mitigate ISF glucose lag.  
     
     
         80 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs heat to mitigate ISF glucose lag.  
     
     
         81 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs vacuum to mitigate ISF glucose lag.  
     
     
         82 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs an electropotential to mitigate ISF glucose lag.  
     
     
         83 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         84 . The system of  claim 77 , wherein the means for mitigating ISF glucose lag employs a combination of at least two of a lag mitigating chemical, ultrasound, heat, vacuum, an electropotential, and mechanical manipulation of the body to mitigate ISF glucose lag.  
     
     
         85 . A system for monitoring an analyte in a bodily fluid of a user, the system comprising: 
 a disposable cartridge including an analysis module for measuring an analyte in the bodily fluid sample; and    a local controller module in electronic communication with the disposable cartridge, the local controller configured to receive measurement data from the analysis module and store the data,    wherein the analysis module includes an analyte sensor configured to be at least partially implanted in the user.    
     
     
         86 . The system of  claim 85 , wherein the analyte sensor is an ISF glucose analyte sensor and wherein the analysis module further includes means for mitigating glucose lag.  
     
     
         87 . The system of  claim 86 , wherein the means for mitigating sensor lag is at least one pressure ring adapted for applying pressure to the user while the analyte sensor is at least partially implanted in the user.